HONG KONG – Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.
Chinese state-backed vaccine developer China National Biotec Group (CNBG), of Beijing, published an interim analysis of randomized phase I/II trials of its inactivated SARS-CoV-2 vaccine candidate in the Journal of the American Medical Association last week. With the added detail, the data encouraged the company in its plans to produce 220 million doses per year.
Big Health’s digital therapeutic Sleepio may not only improve insomnia but also reduce symptoms of depression, a study to be published Aug. 19 in the Journal of Sleep Research shows.
HONG KONG – China’s Lianyungang-based Jiangsu Hengrui Medicine Co. Ltd. has obtained approval from Korea’s Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for a combination therapy of its PD-1 inhibitor candidate camrelizumab and VEGFR-2 inhibitor rivoceranib.
Following a patient’s death in Poseida Therapeutics Inc.’s phase I trial of P-PSMA-101 in metastatic castrate-resistant prostate cancer (mCRPC), the FDA has put the study on clinical hold.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acepodia, Aligos, Arrowhead, Clovis, Deciphera, Follicum, GSK, Immatics, Immunicum, Immutep, Intravacc, Maxcyte, Novartis, Organicell, Poseida, Telix, The University of Texas MD Anderson Cancer Center, Ultimovacs, Vanda.
Shares of Unity Biotechnology Inc. (NASDAQ:UBX) fell 66.6% to $4.15 on Aug. 17 after UBX-0101, its one-time lead candidate, failed to best a placebo on an established measure of osteoarthritis pain in a phase II study.
Chinese state-backed vaccine developer China National Biotec Group (CNBG), of Beijing, published an interim analysis of randomized phase I/II trials of its inactivated SARS-CoV-2 vaccine candidate in the Journal of the American Medical Association last week.
Earlier this month, an update on phase I/IIa data rolled out from Rockville, Md.-based Regenxbio Inc. with RGX-314 for age-related wet macular degeneration (AMD). The company has a pivotal program in subretinal delivery of the compound set to start by the end of this year, and questions about routes of administration – always an issue in AMD – continue to simmer.
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